UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042360 |
|---|---|
| Receipt number | R000048357 |
| Scientific Title | Prospective Study Evaluating Efficacy and Safety of Olanzapine and Aprepitant for Cisplatin-induced Nausea and Vomiting in Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma |
| Date of disclosure of the study information | 2020/11/05 |
| Last modified on | 2023/10/18 14:09:09 |
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Basic information
Public title
Prospective Study Evaluating Efficacy and Safety of Olanzapine and Aprepitant for Cisplatin-induced Nausea and Vomiting in Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma
Acronym
PROACT study
Scientific Title
Prospective Study Evaluating Efficacy and Safety of Olanzapine and Aprepitant for Cisplatin-induced Nausea and Vomiting in Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma
Scientific Title:Acronym
PROACT study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of olanzapine for cisplatin-induced nausea and vomiting in patients with hepatocellular carcinoma treated with hepatic arterial infusion chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Complete response (CR) rate within 120 hours in patients treated with olanzapine
Key secondary outcomes
1) CR rate, complete control (CC) rate and total control (TC) rate within 24 hours
2) CR rate, CC rate and TC rate within 24-120 hours
3) Numerical rating scale scores of nausea, vomiting and anorexia on day 1-6
4) Frequency of vomiting within 120 hours
5) Frequency of rescue antiemetic treatment within 120 hours
6) Frequency, severity and timing of adverse events due to antiemetic treatment
7) Child-Pugh score and ALBI score at 2 weeks and 1 month after treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
<Initial treatment(1)>
Granisetron (GRA) 3mg, just before treatment
Olanzapine (OLA) 5mg, in the morning on day 1 and before bedtime on day 1-4
Interventions/Control_2
<Initial treatment(2)>
GRA 3mg, just before treatment
Interventions/Control_3
<Second treatment(1)>
In addition to initial treatment,
aprepitant (APR) 125mg, in the morning on day 1
APR 80mg, in the morning on day 2, 3
Interventions/Control_4
<Second treatment(2)>
Same as initial treatment
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 20 years old or more
2) diagnosed of HCC according to the JSH guideline (2017)
3) CDDP-HAIC planned within 7 days
4) no prior HAIC within 3 months
5) informed consent obtained
Key exclusion criteria
1) pregnant, possibly pregnant or breastfeeding
2) regular use of olanzapine or other antipsychotic drugs
3) previous participation in this study
4) moderate or severe (NRS 4 or more) nausea
5) considered not appropriate for participating in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Ueno |
Organization
Kurashiki Central Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL
086-422-0210
mu13951@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ueno |
Organization
Kurashiki Central Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL
0864220210
Homepage URL
mu13951@kchnet.or.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee, Kurashiki Central Hospital
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
Tel
086-422-0210
kenkyu@kchnet.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 05 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048357
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| Registered date | File name |
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